Food safety and quality
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OECD Unique Identifier details

MON-15985-7 x MON-88913-8
Commodity: Cotton
Traits: Herbicide tolerance,Insect resistance
Colombia
Name of product applicant: Compañia Agricola S.A.S
Summary of application:

Authorization of the genetically modified cotton MON 15985 X MON 88913 resistant to lepidoptera and pest attack and tolerant to herbicides glyphosate and glufosinate
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Date of authorization: 24/06/2010
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore the National Technical Biosafety Committee for GMO use exclusively in Health and human consumption (CTNSalud) recommends its authorization.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
[email protected]
Organization/agency name (Full name):
Ministerio de salud y proteccion social
Contact person name:
Daniel Rubio
Website:
http://[email protected]
Physical full address:
Carrera 13 No. 32- 76 piso 12, Bogotá
Phone number:
330 5000 ext 1256
Fax number:
Country introduction:

The 4525 decree of 2005, established the Ministry of Health and Social Protection as the competent authority for GMO for health and food purposes and creates the National Biosafety Technical Committee for GMO's used in health and food purposes (CTNSalud).

The CTNSalud is composed by the Ministry of Health and Social Protection, the National Food and Drug Surveillance Institute (INVIMA) and the Technology and Innovation Administrative Department (COLCIENCIAS). This committee is responsible for the assesment of risk assessments; to inquire for any additional information; assessment of any measurements in accordance to the Cartagena Protocol; and the recommendation for the authorization of GMO for health or food purposes.

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Paraguay
Name of product applicant: MONSANTO PARAGUAY S.A
Summary of application:

The stacked cotton line MON88913 x MON15985 expresses several novel proteins: the delta-endotoxins the Cry1Ac and Cry2Ab which confer resistance to lepidopteran pests, and EPSPS (5-enolpyruvylshikimaete-3-phosphate synthase) that confers tolerance to the herbicide glyphosate.

The cry1Ac gene and the cry2Ab gene from Bacillus thuringiensis subsp. kurstaki conferring resistance to lepidopteran pests, and the epsps gene encoding 5-enolpyruvylshikimaete-3-phosphate synthase that confers tolerance to the herbicide glyphosate. gene from Agrobacterium tumefaciens strain CP4.

The cry1Ac and cry2Ab genes, isolated from the common soil bacterium Bacillus thuringiensis (Bt) strain subsp. kurstaki, produce the insect control proteins (delta-endotoxins) Cry1Ac and Cry2Ab. Cry proteins, of which these are only two among many, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow, causing gut paralysis and eventual death due to bacterial sepsis. There are no binding sites for the delta-endotoxins of B. thuringiensis on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.

The line also contains a form of the plant enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) that allows the plant to survive the otherwise lethal application of glyphosate. The glyphosate-tolerant EPSPS gene was isolated from the CP4 strain of the common soil bacterium Agrobacterium tumefaciens.

Glyphosate specifically binds to and inactivates the enzyme EPSPS, which is part of an important plant biochemical pathway called the shikimate pathway. The shikimate pathway is involved in the biosynthesis of the aromatic amino acids tyrosine, phenylalanine and tryptophan, as well as other aromatic compounds. When conventional plants are treated with glyphosate they cannot produce the aromatic amino acids essential to their survival. The modified maize line permits farmers to use glyphosate-containing herbicides for weed control in the cultivation of maize. The EPSPS enzyme is present in all plants, bacteria and fungi, but not in animals, which do not synthesize their own aromatic amino acids. Thus, EPSPS is normally present in food derived from plant and microbial sources.
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Date of authorization: 19/10/2017
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): MON-88913-8 x MON-15985-7
Summary of the safety assessment (food safety):
The food and feed safety assessment was performed following the CODEX Guidelines. The Commercial Release Opinion of the National Commission for Agricultural and Forestry Biosafety (CONBIO), in its substantial part states: "...Recommends technically: (1) The commercial release of the event MON-88913-8 x MON-15985-7 (2) In case of detection of an unexpected effect, the company is obliged to inform CONBIO".
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
[email protected]
Organization/agency name (Full name):
Ministerio de Agricultura y Ganadería
Contact person name:
Santiago Bertoni
Website:
http://conbio.mag.gov.py
Physical full address:
Yegros 437 entre 25 de mayo y Cerro Cora
Phone number:
+595 981 256262
Fax number:
Country introduction:

The agricultural sector is one of the economic pillars of Paraguay in its contribution to the GDP, with the main crops being soybean, cassava, maize, wheat, sugar cane, and cotton. It should also be noted that Paraguay is the world’s fourth exporter of soybean. In 2020, the area planted with crops was 4.67 million hectares and consisted of soybean (3.56 million hectares), maize (1.08 million hectares), and cotton (18,000 hectares). Agricultural biotechnology was first regulated in Paraguay in 1997. In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops” Almost 94% of the soybean, 36% of the maize, and 56% of the cotton planted in the country are GE.

Useful links
CONBIO
Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops
Relevant documents
Stacked events:

When a stacked event is approved, all possible combinations are approved. Previously evaluated single events are not reevaluated in stacks.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

In 2012, the system was adjusted through the creation of the National Agricultural and Forestry Biosafety Commission (CONBIO), “with the mission to manage, analyze, and issue recommendations on all matters related to the introduction, confined field trials, pre-commercial and commercial release, and other intended uses of GE crops”. Additional information https://conbio.mag.gov.py/